Effect of Chinese herbal medicine on food allergy

描述（由申请方提供）：花生过敏（PNA）是致死性和近致死性食物诱导的过敏反应的主要原因之一，目前尚无明确的治疗方法。开发PNA和其他食物过敏的治疗方法的需求是紧迫和具有挑战性的。中国传统医学是世界上最古老的医学实践之一，在中国已经使患者受益数千年，草药被认为是治疗过敏性疾病的潜在草药干预措施。先前的研究表明，食物过敏草药配方（FAHF）-I阻断全身过敏症状和组胺释放，减少肥大细胞脱颗粒，PN特异性血清IgE和Th 2细胞因子分泌，并且在PNA小鼠模型中对肝脏或肾脏功能没有毒性作用，所有这些都可能对花生过敏患者有益。因此，本计画的总体目标是进一步研究治疗食物过敏的中草药，并探讨其作用机制。目标1中的研究将最大限度地减少FAHF-1中的草药数量（11种草药），以生成简化的配方（sFHAF），从而增加草药产品的标准化和安全性。一种新开发的含有9种草药的sFAHF（FAHF-2）在PNA小鼠模型中显示出与FAHF-1相当的治疗效果。将根据FAHF-2中各草药作用的初步数据进一步减少FAHF-2中草药的数量，以确定含有1至3种草药的sFAHF是否具有与FAHF-2相当的治疗作用。如果一个简化的配方是等效的，将进行更严格的标准化方法，以有效地监测草药产品的质量，以及安全性评估。目标#2将确定目标#1中测试的sFHAF对鼠T细胞（包括Th 1、Th 2和Th 3细胞）以及对人T细胞和来自花生过敏患者的嗜碱性粒细胞的影响。在目标#3中，将启动I期和II期临床研究以评价sFHAF在人PNA中的安全性和有效性。这些临床研究将是在花生过敏患者中进行的双盲、随机、安慰剂对照和多剂量试验。实现这些目标将是至关重要的，在验证可能的临床用途中的中草药在PNA，并了解其作用机制。这些研究可能导致治疗PNA和其他IgE介导的食物过敏的新方法。

DESCRIPTION (provided by applicant): Peanut allergy (PNA) is one of the major causes of fatal and near fatal food induced-anaphylactic reactions and at this time there is no definitive therapy. The need to develop treatments for PNA and other food allergies is urgent and challenging. Traditional Chinese Medicine, one of the oldest medical practices in the world, has benefited patients for thousands of years in China and herbal medicines have been suggested as potential herbal interventions for treating allergic disorders. Previous studies showed that Food Allergy Herbal Formula (FAHF)-I blocked systemic anaphylactic symptoms and histamine release, reduced mast cell degranulation, PN-specific serum IgE and Th2 cytokine secretion, and had no toxic effects on liver or kidney functions in a murine model of PNA, all of which could be of benefit to peanut allergic patients. Thus, the overall goals of this project are to further investigate Chinese herbal medicine for treating food allergy and to explore the mechanisms of its effects by pursuing three specific aims. Studies in Aim # 1 will minimize the number of herbs in FAHF-1 (11 herbs) in order to generate a simplified formula (sFHAF) to increase ease of standardization and safety profiles of the herbal product. One newly developed sFAHF (FAHF-2) containing 9 herbs shows therapeutic efficacy equivalent to that of FAHF-1 in the mouse model of PNA. Further reduction in the number of herbs in FAHF-2 will be carried out based upon preliminary data on the effects of the individual herbs in FAHF-2 to determine if sFAHF containing 1 to 3 herbs will have therapeutic effects comparable to FAHF-2. If a simplified formula is equivalent, more rigorous standardization methods will be performed to effectively monitor the quality of herbal product, as well as safety assessment. Aim#2 will determine the effects of sFHAF tested in Aim#1 on murine T cells including Th1, Th2 and Th3 cells and on human T cells and basophils from peanut allergic patients. In Aim #3, Phase I and II clinical studies will be initiated to evaluate the safety and efficacy of the sFHAF in human PNA. These clinical studies will be double blind, randomized, placebo controlled and multiple dose trials in peanut allergic patients. Accomplishing these aims will be of fundamental importance in validating the possible clinical usefulness of Chinese herbal medicine in PNA, and understanding the mechanisms of actions. These studies may lead to a novel approach for treating PNA, and other IgE mediated food allergies.